CRN East Midlands managed recovery FAQs
What is the managed recovery process?
In order to support a sustainable UK-wide recovery of health and care research following the impact of the pandemic, and in response to feedback from partners and stakeholders, a managed approach to the recovery of the UK research portfolio is being implemented.
The approach has been developed through the UK Clinical Research Recovery, Resilience and Growth (RRG) Programme with input from a broad range of stakeholders including funders, sponsors, NHS R&D, and patient and public representatives.
The managed recovery approach seeks to coordinate and sequence the delivery of a subset of multi-centre studies while enabling sites to manage the delivery of their wider local portfolio, in particular single centre studies. Studies which are already open and recruiting successfully should not be paused as a result of this process.
This guidance intends to provide a broad set of principles for the selection of studies to aid the recovery of a balanced research portfolio over the next 6-12 months.
It recognises the challenges being faced by NHS R&D and research delivery teams, who have made a critical contribution to the national and global effort to tackle COVID-19, and seeks to support them in managing the evolving situation on the ground and their own wellbeing. It also recognises that the delivery of care and research has been irreversibly changed during the pandemic, with new care pathways in particular necessitating new approaches.
This guidance calls for a coordinated effort across all partners to support the recovery of the portfolio in the national interest. This time-limited managed recovery aims to speed up that process and build on the partnerships and collective action which enabled the nation’s collective success over the eighteen months.
What is the aim of managed recovery?
The aim of the process is to review each study selected by non-commercial funders and commercial sponsors and undertake an assessment of whether the study is deliverable at a national level in the current research and clinical environment.
Studies deemed deliverable at a national level following the delivery assessment will be highlighted as such by being added to the managed recovery list, and will then be managed following standard business as usual study support processes.
What is a study delivery assessment?
A delivery assessment will be undertaken for each selected study to determine if the study is deliverable at a national level in the current research and clinical environment. The aim of the assessment is to understand any challenges or blockers associated with the study, including at site level, in order to determine if the study is deliverable.
The assessment will also capture any recommendations required to support delivery (e.g. NIHR CRN support with the identification of additional sites or recommendations for amendments to the study design to reflect new patient pathways).
How does the managed recovery process work?
There are two stages to the managed recovery process. For non-commercial studies, stage 1 concerns locally led studies only and involves a Data Integrity Check (i.e. confirmation of study open date, recruitment target) and a high level overview of the study with the Chief Investigator/study team/sponsor.
Stage 1 for non-commercial studies is performed by CRN East Midlands. For commercial studies, the stage 1 delivery assessment will be completed by the CRN Coordinating Centre.
If more information is needed to help conclude whether the study is deliverable or not at a national level, the study will progress to a full stage 2 delivery assessment. This will involve clinical intelligence from the National Specialty Lead (NSL) via the CRN Coordinating Centre, and all participating sites will be contacted to gather local intelligence on deliverability of the study. The following measure will be used to determine progress from stage 1 to stage 2:
50% of open sites have recruited participants in the last month. Further consideration will be given to ‘rare disease’/ known low recruiting studies.
Clinical knowledge that participants are available to be recruited and that NHS services are available to deliver the protocol.
Chief Investigator and sponsor/funder intelligence (where available) confirms no known problems with the study.
Who has decided which studies are included within managed recovery?
Studies have been selected by non-commercial funders and industry sponsors. More recently for non-commercial studies, CRN National Specialty Leads, in conjunction with the relevant local leads, have also identified studies to be included in the managed recovery process.
Are managed recovery studies prioritised over other studies on the portfolio?
Studies which are already open and recruiting should not be paused in anticipation of, or as a result of, this process. It is the decision of each site/NHS Trust to decide whether to restart managed recovery studies or become a new site. We understand that organisations are facing competing demands at the moment and capacity is stretched.
How are managed recovery studies being shared?
Lists of these sequenced studies are being shared with stakeholders and partners as they become available.
How long will managed recovery last?
On the 25th August 2021, the CRN Coordinating Centre announced that no new studies will be added to the managed recovery process. However, there are likely to be a small number of studies already in the system that are yet to have a completed deliverability review.
Why is there a deadline of five days to submit feedback for a managed recovery study?
Conversations with our stakeholders indicated time was of the essence, therefore this timeline was agreed with the Department of Health and Social Care.
What happens when the managed recovery process is put on hold for a study?
Studies included in the managed recovery process are sometimes placed on hold whilst further information is collected or the study is awaiting a study amendment approval, or if the challenges identified cannot be rectified at this time. Participating sites will be informed once studies are confirmed as deliverable or not deliverable.
Do we have to agree to deliver a managed recovery study if we are an existing site?
The managed recovery process is not a prioritisation process. The decision on how to proceed with managed recovery studies lies with each site. CRN East Midlands understands that organisations are facing competing demands at the moment and capacity is stretched. We will continue to support your decisions.
Where a site has confirmed that a study is deliverable and that the target is achievable as part of the managed recovery process, it is expected that the site delivers the study.
Do we have to agree to deliver a managed recovery study if we are invited to participate as a new site?
The managed recovery process is not a prioritisation process. The decision on how to proceed with managed recovery studies lies with each site. CRN East Midlands understands organisations are facing competing demands at the moment and capacity is stretched. We will continue to support your decisions.
Can we change our recruitment target for a managed recovery study?
This is possible, please speak with the study team.
How are managed recovery studies measured?
There are two High Level Objectives measuring the success of the managed recovery process. Both objectives are to enable managed recovery studies to fully recruit and/or close in the next financial year (2021/22):
- 70% of non-commercial studies in the managed recovery process achieving or surpassing their recruitment target during their planned recruitment period. This is set at national level.
- 80% of commercial contract studies in the managed recovery process achieving or surpassing their recruitment target during their planned recruitment period.